Table 3:

Adverse Events By Treatment Course

Worst Grade AEs by Treatment Course
During Course 1 (n=50)
AE / Grade	G1	G2	G3	G4
Allergic rhinitis	1 (2%)
ALT, SGPT	23 (46%)	6 (12%)	4 (8%)	1 (2%)
Anorexia	2 (4%)
AST, SGOT	6 (12%)		2 (4%)
Bilirubin	2 (4%)	2 (4%)		1 (2%)
Bleeding other	3 (6%)
Colitis	1 (2%)
Constipation	3 (6%)
Cough	5 (10%)
Creatinine	3 (6%)
Diarrhea	11 (22%)		2 (4%)
Dizziness	2 (4%)
Edema, head & neck	1 (2%)
Fatigue	27 (54%)
Febrile Neutropenia	2 (4%)		37 (74%)
Fluid Overload	1 (2%)
Hypokalemia	3 (6%)
Hypophosphatemia	1 (2%)
Infection-Other	1 (2%)	1 (2%)	2 (4%)
Insomnia	2 (4%)
Mood alteration/anxiety	1 (2%)
Mucositis	16 (32%)	1 (2%)
Nausea	13 (26%)
Other	1 (2%)		1 (2%)
Otitis	2 (4%)
Pain	11 (22%)
Peri-orbital pain	1 (2%)
Petechiae/purpura/bruising	2 (4%)
Pruritis/Itching	1 (2%)
Rash/desquamation	13 (26%)		1 (2%)
Seizure	1 (2%)
Thrombosis/thrombus/embolism	3 (6%)
Tinnitus	1 (2%)
Vomiting	2 (4%)
Weight loss	1 (2%)
During Course 2 (n=44)
Acidosis	1 (2%)			1 (2%)
ALT, SGPT	4 (9%)	1 (2%)	1 (2%)	6 (14%)
AST, SGOT	1 (2%)			1 (2%)
Bilirubin		1 (2%)		1 (2%)
Blurriness	1 (2%)			1 (2%)
Cough	2 (5%)			2 (5%)
Diarrhea	2 (5%)			2 (5%)
Dyspnea	1 (2%)			1 (2%)
Fatigue	2 (5%)			2 (5%)
Febrile Neutropenia			8 (18%)	8 (18%)
Fistula, GI	1 (2%)			1 (2%)
Infection-Other			2 (5%)	2 (5%)
Mucositis	1 (2%)			1 (2%)
Nausea	2 (5%)			2 (5%)
Other	1 (2%)			1 (2%)
Pain	2 (5%)			2 (5%)
Petechiae/purpura/bruising	2 (5%)			2 (5%)
Respriatory Distress	1 (2%)			1 (2%)
Syncope	1 (2%)			1 (2%)
Vomiting	2 (5%)			2 (5%)
During Course 3 (n=18)
ALT, SGPT			1 (6%)
AST, SGOT	1 (6%)
Febrile Neutropenia			2 (11%)
Other	1 (6%)
Pain	1 (6%)